BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 1616630 · Received February 22, 2010

    Report

    Report Number
    1219913-2010-00022
    Event Type
    Other
    Date Received
    February 22, 2010
    Date of Event
    February 3, 2010
    Report Date
    February 4, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATED THAT THE CAUSE FOR THE FALSE POSITIVE (B)(6) RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A NEGATIVE ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED FOR A PT SAMPLE AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT SINCE THE RESULT DID NOT MATCH THE PT'S HISTORICAL RESULT. THE CUSTOMER REPEATED TESTING. THE (B)(6) RESULT WAS POSITIVE. A CORRECTED REPORT WAS ISSUED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 145

    Patients

    Seq Age Sex Outcome Treatment
    1